Neonatal TPN Starter Bag 10% (D-1121-2023) Recall: Sterility Concern
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy…
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was Neonatal TPN Starter Bag 10% recalled?
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
Which lot codes, UPCs or models are affected?
Lot# 36-262161, Exp 8/21/2023 ;
- Agency record number
- D-1121-2023
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy…
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 92 bags
- Distribution
- Nationwide in the USA
- Recall started
- August 17, 2023
- Report date
- September 6, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)